2422.06 Requirement for Statement Regarding Information Contained in the “Sequence Listing” and Separate Computer Readable Form [R-07.2022]

2422.06 Requirement for Statement Regarding Information Contained in the “Sequence Listing” and Separate Computer Readable Form [R-07.2022]

[Editor Note: This section is not applicable to applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b). See MPEP §§ 2412–2419 for guidance on WIPO ST.26 requirements for applications filed on or after July 1, 2022.]

When a separate computer readable form (CRF) of a “Sequence Listing” is submitted in an application filed under 35 U.S.C. 111(a) because the “Sequence Listing” is filed as a PDF image file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) (see 37 CFR 1.821(e)(1)(i)) or filed in a national stage application submitted under 35 U.S.C. 371 because the “Sequence Listing” is filed as a PDF image file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) and not also as an ASCII plain text file in compliance with 37 CFR 1.824 (see 37 CFR 1.821(e)(2)(i)), 37 CFR 1.821(e)(1)(ii) and (2)(ii) require, a statement that the information contained in the “Sequence Listing” and the separate CRF are identical. When a CRF is submitted in the international stage of an international application under the PCT in response to an notice requesting a ASCII plain text formatted sequence listing by the United States International Searching Authority or by the United States International Preliminary Examining Authority because a sequence listing in ASCII plain text format in compliance with 37 CFR 1.824 has not been filed (see 37 CFR 1.821(e)(3)(i)), 37 CFR 1.821(e)(3)(iii) requires a statement that the information contained in the CRF does not go beyond the disclosure in the international application as filed or a statement that the information recorded in the ASCII plain text file of the CRF is identical to the sequence listing contained in the international application as filed, as applicable. Such a statement may be made by a registered practitioner, the applicant, an inventor, or the person who actually compares the sequence data on behalf of the aforementioned. See MPEP § 2428 for further information and Sample Statements.

Note that, in an application filed under 35 U.S.C. 111(a), if a “Sequence Listing” is filed as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc under 37 CFR 1.52(e), and applicant has not filed a “Sequence Listing” as a PDF image file or on physical sheets of paper, the ASCII plain text file will serve as both the “Sequence Listing” required by 37 CFR 1.821(c) and the computer readable form (CRF) required by 37 CFR 1.821(e) (37 CFR 1.821(e)(1)). Also, in a national stage application submitted under 35 U.S.C. 371, if a “Sequence Listing” is filed as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc under 37 CFR 1.52(e), the ASCII plain text file will serve as both the “Sequence Listing” required by 37 CFR 1.821(c) and the computer readable form (CRF) required by 37 CFR 1.821(e). See MPEP § 2422.03(a), subsection I, for additional information. See also MPEP § 2422.03(a) subsection IV, for additional information regarding international stage applications. Thus, for applications filed under 35 U.S.C. 111(a) and 35 U.S.C. 371, the following are not required and should not be submitted: (1) a second copy of the “Sequence Listing” as a PDF image file or on physical sheets of paper; and (2) a statement under 37 CFR 1.821(e)(1)(ii) or (2)(ii) (indicating that the sequence information contained in the “Sequence Listing” under 37 CFR 1.821(c) and CRF copy of the “Sequence Listing” under 37 CFR 1.821(e)(1)(ii) or (2)(ii) are identical).